Sertraline effective in pediatric depression

Two recent warnings have led to concerns about the risks of prescribing antidepressants to children. Researchers, however, have just published a study that indicates that sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), is an effective and well-tolerated treatment for children and adolescents with major depressive disorder (MDD).

Fluoxetine (Prozac), another SSRI, is the only newer antidepressant that is approved by the FDA for use in children. This summer, the U.S. Food and Drug Administration (FDA) announced it was reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents younger than age 18 treated with the drug paroxetine (Paxil) for MDD. Then in August, Wyeth Pharmaceuticals said it was not recommending the use of venlafaxine (Effexor) in pediatrics because of increased reports among those patients on the drug of hostility and suicide-related adverse events.

Researchers in the sertraline trials, however, did not find a significant difference in suicidal ideation between patients treated with the drug and those treated with placebo. The one episode of suicidal ideation reported in the study was attributed by investigators to teasing by classmates, not to treatment with sertraline.

The sertraline trials were developed in response to an FDA written request. To evaluate the efficacy and safety of sertraline compared with placebo in treatment of pediatric patients with MDD, the researchers studied 376 children and adolescents ages 6-17 years with MDD of at least moderate severity, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth ed. Patients were randomly assigned to receive a flexible dosage (50-200 mg/d) of sertraline or placebo for 10 weeks. The researchers then measured the change from baseline in the Children’s Depression Rating Scale-Revised (CDRS-R) Best Description of Child total score and adverse events.

By the end of the study, 69% of the sertraline-treated patients had improved, compared with 59% of the placebo patients. These findings suggest that children are more responsive to placebo than adults, says Christopher K. Varley, MD, who wrote an accompanying editorial. Varley is professor of child and adolescent psychiatry at the University of Washington School of Medicine in Seattle.

He concludes that current evidence continues to support the use of SSRIs, particularly fluoxetine and sertraline, in the treatment of MDD in children and adolescents.

The researchers report that the sertraline treatment was generally well tolerated in the trials. Seventeen patients treated with sertraline and five placebo patients prematurely discontinued the study because of adverse events. Adverse events that occurred in at least 5% of sertraline-treated patients and with an incidence of at least twice that in placebo patients included diarrhea, vomiting, anorexia, and agitation.